IN THE SUPREME COURT OF INDIA(CIVIL ORIGINAL JURISDICTION)WRIT PETITION (CIVIL) NO.________ OF 2016
(PUBLIC INTEREST LITIGATION)

IN THE MATTER OF:

S. SRINIVASAN…

PETITIONER

VERSUSUNION OF INDIA & OTHERS...

RESPONDENTS

PAPERBOOK(KINDLY SEE INSIDE FOR INDEX)ADVOCATE FOR THE PETITIONER: PRASHANT BHUSHANSYNOPSIS AND LIST OF DATESThe petitioner herein is filing the instant writ petition in public interest
under Article 32 of the Constitution of India for the enforcement ofrights under Article 14 and 21 of the citizens seeking a writ directing
the respondents to make public the segregated data (center-wise
results) of the Rotavac clinical trial (phase III) that was conducted on
6799 infants at three centres namely Delhi, Pune and Vellore between
2011-2013 to gauge the safety and efficacy of the said vaccine. The
petitioner at this stage is not casting aspersions on the efficacy of thesaid vaccine but is only asking for complete segregated data to beprovided. The segregated data is crucial to know if the vaccine is safe
in all areas or if some groups are more susceptible to adverse eventsfrom the vaccine. The very raison d’etre of such multicenter trials is tocompare results among centers. This data should have been
examined by the National Technical Advisory Group on Immunization(NTAGI) in public interest but such is the secrecy surrounding it, it has
not been provided even to this apex body. The instant petition is
asking for the data to be provided to the petitioner or made available in
the public domain.

Facts of the CaseOn 26th March 2016, the Ministry of Health officially launched
Rotavirus vaccine to combat deaths in infants caused due to diarrhea.
Before the launch of the vaccine, a clinical trial (phase III) was
conducted between 2011 and 2013 at three centres namely Delhi,
Pune and Vellore to gauge the efficacy and safety of the said vaccine.
Under this clinical trial, 6799 infants were administered the saidvaccine to ensure its safety in terms of the number of intussusceptionsin the 2-year trial period. Intussusceptions are intestinal obstructions
that may need an urgent surgery to prevent death among infants, andis diagnosed by ultra sound examination. The trial was done as per
protocol to test the risk of this potentially fatal side-effect of thevaccine over an observation period of 2 years. Multiple trial sites wereincluded to ensure different geographic areas to include a wider rangeof population groups with allows comparison of results among centers
and increases the generizability of the study..

The aggregated results of the study published in UK Journal “Vaccine”
issue dated August, 2014 raised certain questions about the efficacyof the vaccine and the risks associated with it. Through theseaggregated results, an expert member of the National TechnicalAdvisory Group on Immunization (NTAGI), which is the apex advisory
body of the Government of India on immunization, Dr. Jacob Puliyel
deduced that the number of cases of intussusceptions in the infants
who were administered ‘rotavirus’ vaccine in Vellore centre were thehighest and there was a huge difference in the number of cases ofintussusceptions between result in Delhi and Vellore. As a member of
NTAGI, Dr. Puliyel considered it his duty to study the segregatedresults of the clinical trial data from all the three centres to ascertain if
a certain population was more susceptible to the side effects of thesaid vaccine. However, the respondents did not publish the centrewise results of the said trial.

In his capacity as the member of NTAGI, Dr. Puliyel repeatedly maderequests for the said results but the results were not provided to him.
Dr. Puliyel made several representations to the Director, CMC Vellore
requesting for the data for Vellore limb of the study. His request was
not acceded to. He also wrote to the NTAGI by writing emails
addressed to Dr. Vijaya Raghavan, Chairperson of Standing Technical
Sub-Committee (STSC) of NTAGI (and copying to all members of
NTAGI) requesting for the disaggregated data from Vellore in theformat provided by him as a member of NTAGI. However, the resultsfrom Vellore were not provided.

It is submitted that not providing complete results of clinical trials
involving human beings is in violation of ethics of medical researchand global norms governing clinical trials. Raising this issue, journal

Vaccine published a detailed letter dated 06.10.2014 asking forsegregated centre-wise results of the clinical trial to be published. As aresult of the letter many newspapers through their sciencecorrespondents tried to get the information directly from the Principal
Investigator but the respondents did not provide the said data from thethree centres.

In the mean time, an NGO also filed an RTI application seeking
information on a.) the number of cases of intussusceptions diagnosed
as ‘Possible intussusception’ (meaning exhibiting clinical evidence of
intussusception diagnosed by the trial doctor as described in the study
protocol) and numbers with ultrasound evidence of intussusception in
the 1000 infants given the rotavirus vaccine in Vellore limb of study
over the period of 2 years and, b.) what is the corresponding figure forthe 500 who were placebo recipients. But no reply was given to the
RTI application by the respondents.

In response to Dr. Puliyel letter to the Prime Minister dated
16.06.2015, the Prime Minister’s Office made a request to the Subject
Expert’s Committee to look at the data from Vellore. As per theminutes of the meetings of SEC dated 29.07.2015, the same has not
yet been complied with. This shows that not only the NTAGI but even
the Subjects Expert Committee has not examined the Vellore data
even after a reference for the same by the PMO.

Why is it important to disclose centre-wise data
The petitioner submits that there is a need for disclosure of thesegregated data of Vellore Centre in order to ascertain whether acertain section of the population is more susceptible to adverse
effects. This was the very objective of the multi-centre clinical trial. So
far the respondents have shown complete secrecy in the matter andhave not disclosed segregated ( meaning dis-aggregated) data fromall the centres and have only released aggregated data i.e. the resultsof all three centres clubbed together. Concealing of this vital data does

severe injustice to the thousands of infants who participated in thisstudy, the researchers who painstakingly conducted the trials and the
medical/scientific community who depend on this data for their work. It
is even more crucial to study the segregated data because therespondents have now launched the vaccine in 4 states in the country
where lakhs of infants might be administered the vaccine. It is
submitted that informed consent requires the disclosure of safety data,and it would be unethical to proceed with immunisation without
informing the public of any risks observed with previous use of thevaccine, and not informing them what adverse effects to look out for.

Earlier Petition seeking the same relief
Aggrieved by the attitude and callousness on the part of the
respondents, Dr. Jacob Puliyel filed Writ Petition No.6913 of 2015
before the Hon’ble High Court of Delhi praying for the ethicaldisclosure of the disaggregated data of all the centres where the study
was conducted. In the said matter, Vide order dated 14.10.2015, theHon’ble High Court had dismissed the said writ petition on the groundthat segregated trial result of all the three centres was available with
the National Technical Advisory Group on Immunization (NTAGI) of
which the petitioner is a member and that it was on the basis of thisdata that the NTAGI approved the said vaccine.

The Hon’ble High Court failed to appreciate the fact that the
segregated results of the clinical trial were not made available tomembers of the NTAGI in spite of written requests for the same by Dr.
Puliyel. Aggrieved by the order, Dr. Puliyel was constrained to filed an
SLP (Civil) No.2532 of 2016 against the Order dated 14.10.2015 of the
Hon’ble High Court of Delhi. On 05.02.2016 the Hon’ble Court while
keeping all questions open expressed its inability to entertain the said
SLP on the ground that the petitioner therein, who was a member of
the NTAGI, cannot maintain a public interest petition. The Hon’ble
Court in the said order dated 05.02.2016 in SLP (C) No.2532 of 2016
stated as under:Learned counsel for the petitioner seeks leave to withdraw thispetition. This petitioner cannot maintain a petition in public
interest since he was a member of the National TechnicalAdvisory Group on Immunization which recommended theintroduction of the vaccine in question. Leave to withdraw is
granted. The special leave petition is dismissed as withdrawn.
All questions are left open.

Therefore, the petitioner herein has filed the instant writ petition
espousing the same cause of ethical and complete disclosure ofclinical trial conducted on human beings. Since the High Court has
already expressed its views in the matter, the petitioner herein seeks
the intervention of this Hon’ble Court to set aside the Order dated
14.10.2015 of the High Court of Delhi and to direct the respondents todisclose and publish the segregated results of the clinical trial of
Rotavac vaccine conducted on 6799 infants in the period between
2011-2013 at Delhi, Pune and Vellore. The petitioner also seeks aninterim direction that the segregated results from all the three centres
be placed before the NTAGI, which is the expert body on
immunization policy, for examination and scrutiny.

List of Dates
Dates

Events11.03.2011

Department of Biotechnology, Ministry of Science andTechnology, Government of India conducted a Phase III
randomized,

double-blind,placebo-controlled

trial,

hereinafter “the clinical trial”, of 116E rotavirus vaccine.
The study was conducted at three centres namely Pune,
Delhi and Vellore.

October 2013

Revised version of Declaration of Helsinki is adopted
which states that “Every research study involving humansubjects must be registered in a publicly accessible
database before recruitment of the first subject.” and that

“Researchers have a duty to make publicly available theresults of their research...." Negative and inconclusive as
well as positive results must be published or otherwise
made publicly available”.

05.11.2013

The above mentioned clinical trial was completed.

March 2014

Lancet published a paper on the said study. However thepaper did not provide segregated data for different
centres of the clinical trial.

August 2014

Questions about the efficacy and the risk associated withthe rotavirus vaccine were raised in a paper authored byJohn and colleagues published in journal Vaccine titled‘Active surveillance for intussusception in a phase III
efficacy trial of an oral mono-valent rotavirus vaccine in
India’

06.10.2014

The Vaccine published a detailed letter dated 06.10.2014
asking for this data to be published but the Principal
Investigator has not responded to this scientific appeal.
March 2015 The Prime Minister launched Rotavirus
vaccine Rotavac, developed by Hyderabad-based Bharat
Biotech. The said vaccine has been ostensibly approvedby the government after a clinical trial conducted togauge its efficacy and safety

14.04.2015

World Health Organization (WHO) released a strong
statement advocating for public disclosure of all clinical
trial results. According to it, when data is not released itmeans that doctors, patients and medical regulators
cannot make informed decisions about which treatments
are best. Non-disclosure of complete clinical trial resultsmeans that hundreds of thousands of patients havevolunteered to take part in clinical trials where results
have been kept hidden or are only selectively disclosed.

12.05.2015

One of the largest online campaigning communities
called Avaaz.org starts a campaign requesting the
Director, CMC Vellore to release the clinical trial data. As
of now campaign has 442 signatories from the world overbut no response has been received so far from CMC
Vellore. The online petition can be accessed at:https://secure.avaaz.org/en/petition/To_The_Director_Ch
ristian_Medical_College_Vellore_632004_Release_India
n_Rotavirus_Vaccine_Trial_Data/.

21.05.2015

Dr. Puliyel made representations to Mr. Sunil Chandy,
Director of CMC Vellore requesting the for the data for
Vellore limb of the study. His request was not accededto.

26.05.2015

An NGO filed an RTI application seeking information on
the number of cases of intussusceptions in Vellore limb
of study. No response has been received for the same.

28.05.2015

Dr. Puliyel, as a member of NTAGI wrote a letter to Dr.
Vijaya Raghavan, Chairperson of Standing Technical
Sub-Committee (STSC), NTAGI and copied to allmembers of NTAGI requesting for the disaggregateddata from Vellore in the format provided by him as amember of NTAGI on or before the meeting of the STSC
that was scheduled for June 10. However, his request
was not acceded to.

30.05.2015

The Hindu published an article stating that theGovernment now plans to study the vaccine in 100,000
infants, without providing evidence of safety in the 1000
children already studied in Vellore.

16.06.2015

Dr. Puliyel wrote letter to the Prime Minister apprising
him of the situation and requesting him to enquire into
the matter.

22.06.2015

The Prime Minister's Office (PMO) made a reference
(PMO

ID

No.

4219998//2015

dated

22.06.2015)

forwarding the concerns over the SAE of intussusception
in children in recently launched indigenous Rotavirus
vaccine (Rotavac).

07.2015

Writ Petition (Civil) No. 6913 of 2015 was filed at the
Hon’ble High Court of Delhi praying for the segregatedtrial research from all the three centres.

29.07.2015

Minutes of the Meeting of Subject Expert Committee(SEC) – Vaccine show that even after the PMO
reference dated 22.06.2015, the SEC did not review thedata with respect to Vellore limb of the study and gave its
opinion based on the already published data in thejournal Vaccine.

14.10.2015

The Hon’ble High Court of Delhi dismissed Dr. Puliyel’s
petition on the ground that the entire data was in fact
available with NTAGI despite the fact that the petitioner
therein was himself a member of NTAGI and was neverprovided the disaggregated data.

12.01.2016

Dr. Puliyel thereafter preferred SLP (C) 2532 of 2016
against the impugned order dated 14.10.2015 of thedivision bench of the Hon’ble High Court of Delhi at New
Delhi.

05.02.2016

The Hon’ble Court in SLP (C) 2532 of 2016 stated its
inability to entertain the said SLP on the ground that thepetitioner therein, who was a member of the NTAGI,
cannot maintain a public interest petition. The Hon’ble
Court in its order dated 05.02.2016 in SLP (C) No. 2532
of 2016 stated as under: Learned counsel for thepetitioner seeks leave to withdraw this petition. This
petitioner cannot maintain a petition in public interest
since he was a member of the National TechnicalAdvisory Group on Immunization which recommended
the introduction of the vaccine in question. Leave towithdraw is granted. The special leave petition is
dismissed as withdrawn. All questions are left open.

26.03.2016

Rotavac vaccine is launched in four states in the country
with plans to include it in the Universal Immunization
Policy of the government of India

23.04.2016

The petitioner herein Mr. S. Srinivasan files the instant
Writ Petition

IN THE SUPREME COURT OF INDIA
CIVIL ORIGINAL JURISDICTIONWRIT PETITION (CIVIL) NO. OF 2015

IN THE MATTER OF:S. SRINIVASAN
S/O SATAGOPAN SOURIRAJAN
R/O 1 TEJAS APTS, 53 HARIBHAKTI COLONY, OLD PADRA RD.,VADODARA 390007
MANAGING TRUSTEE,LOCOST (LOW COST STANDARD THERAPEUTICS),VADODARA, GUJARATEMAIL: CHINUSRINIVASAN.X@GMAIL.COM
PH NO.: 8860867102/ 9998771064.... PETITIONER

VERSUS
1. THE UNION OF INDIA
THROUGH ITS SECRETARYMINISTRY OF HEALTH & FAMILY WELFARE
NIRMAN BHAWAN, NEW DELHI-110001

2. THE UNION OF INDIA
THROUGH ITS SECRETARYDEPARTMENT OF BIO-TECHNOLOGYMINISTRY OF SCIENCE AND TECHNOLOGY
6TH-8TH FLOOR, BLOCK 2CGO COMPLEX, LODHI ROAD
NEW DELHI - 110 003

3. CHRISTIAN MEDICAL COLLEGE
THROUGH ITS DIRECTOR
CMC VELLORE, 632004
TAMIL NADU...RESPONDENTS

.To,
The Chief Justice of the Hon’ble Supreme Court of India and his
companion Justices of the Supreme Court of India:

MOST RESPECTFULLY SHOWETH:

1. The petitioner herein is filing the instant writ petition in public
interest under Article 32 of the Constitution of India for theenforcement of rights under Article 14 and 21 of the citizens
seeking a writ directing the respondents to make public thesegregated data (result) of the Rotavac clinical trial (phase III)
involving 6799 infants, that was conducted at three centres namely
Delhi, Pune and Vellore to gauge the safety and efficacy of the saidvaccine.

2. The Petitioner is Mr. S. Srinivasan. He is the Managing Trustee of(Low Cost Standard Therapeutics), Vadodara, Gujarat. The
petitioner is an expert and has been active for over 35 years in thefield of health care, low cost medicine manufacture, transfer ofpharmaceutical technology to LDCs, issues of disadvantaged
children and human rights, and relief in disaster situations. He is anactive member of the Medico Friend Circle and AIDAN (All-India
Drug Action Network) among others. Mr. S. Srinivasan is a
graduate and postgraduate of IIT Kharagpur and IIM Bangalore. His
recent books include A Lay Person’s Guide to Medicine (2000/2006
and 2012 in Hindi), Impoverishing the Poor: Pharmaceuticals andDrug Pricing in India as well as several articles pharma policy, drug
pricing and related issues in the Economic and Political Weekly aswell as contributed chapters in books. The petitioner, through
LOCOST, has previously filed petitions in the Supreme Court oninter alia irrational medicines, drug pricing policy, vaccine PSUs
closure and HPV vaccine related deaths. His annual income is of
Rs. 5,00,000. His PAN Card No. is AFVPS3170B.

3. The petitioner has filed the instant writ petition in public interest
under Article 32 of the Constitution of India for the enforcement ofrights under Article 14 and 21 of the citizens seeking a writ directing
the respondents to make public the segregated results of the
Rotavac clinical trial (phase III) conducted between 2011 and 2013
at Delhi, Pune and Vellore. The clinical trial involved administering
the rotavac vaccine to 6799 infants with an objective of ascertaining
and ensuring the safety and efficacy of the said vaccine at all thethree centres. The petitioner herein is also seeking the interventionof this Hon’ble Court to is also seeking a relief in the form of adirection from this Hon’ble Court to direct the respondents to place
before the NTAGI the entire clinical trial results in segregatedmanner so that the NTAGI may examine and scrutinize the resultsof the said vaccine.

4. NTAGI is the country’s apex advisory committee that provides
guidance to the national policy makers on immunization. Membersof NTAGI include officials from MoHFW; representatives from
immunization action partners such as WHO, UNICEF, the Indian
Academy of Pediatrics and the Indian Medical Association ; andleading independent experts from diverse fields such as clinicalmedicine, public health, immunology, vaccinology, immunization
program etc.

Facts of the Case
5. On 26th March 2016, the Ministry of Health officially launched
Rotavirus vaccine to combat deaths in infants caused due todiarrhea. Before the launch of the vaccine, a clinical trial (phase III)was conducted between 2011 and 2013 at three centres namely
Delhi, Pune and Vellore to gauge the efficacy and safety of the saidvaccine. Under this clinical trial, 6799 infants were administered thesaid vaccine to ensure its safety in terms of the number of
intussusceptions in the 2-year trial period. Intussusceptions areintestinal obstructions that may need an urgent surgery to prevent
death among infants, and is diagnosed by ultra sound examination.
The trial was to test the risk of this potentially fatal side-effect of thevaccine.

6. The aggregated results of the study published in UK Journal‘Vaccine’ issue dated August, 2014 raised certain questions about
the efficacy of the vaccine and the risks associated with it. A paper
authored by John and colleagues published in journal Vaccine titled‘Active surveillance for intussusception in a phase III efficacy trial ofan oral mono-valent rotavirus vaccine in India’ showed that theintusseption rate in Vellore was almost 20 times the rate in Delhi. A
copy of the said paper published in journal Vaccine by John &Colleagues is annexed as Annexure P1 (Pages_____to ____).

7. Through these aggregated results, Dr. Jacob Puliyel of the National
Technical Advisory Group on Immunization (NTAGI), which is the
apex advisory body of the Government of India on immunization,
came to know that the number of cases of intussusceptions in theinfants who were administered rotavac vaccine in Vellore centre
were the highest.

8. As a member of NTAGI, Dr. Puliyel considered it his duty to study
the segregated results of the clinical trial data from all the three
centres to ascertain if a certain population was more susceptible tothe side effects of the said vaccine. The respondents whilecelebrating the launch of the vaccine, had not disclosed complete
segregated data (centre-wise results) from these three centres
where this clinical trial was conducted. In his capacity as themember of NTAGI, he repeatedly made requests for the said
results but the results were not provided to him. Not providing
complete results of clinical trials involving human beings is inviolation of ethics of medical research and global norms governing
clinical trials.

9. Raising this issue, journal Vaccine published a detailed letter dated
06.10.2014 asking for segregated or dis-aggregated results of theclinical trial to be published. As a result of the letter many
newspapers through their science correspondents tried to get the
information directly from the Principal Investigator but the
respondents did not provide the said data from the three centres. A
copy of the letter dated 06.10.2014 published in journal Vaccine isannexed as Annexure P2 (Pages_______to_______).

10.

Dr. Puliyel made several representations to the Director, CMC

Vellore requesting for the data for Vellore limb of the study. His
request was not acceded to. A copy of his email correspondence
between 21.05.2015 and 28.05.2015 with Mr. Sunil Chandy,
Director,

CMC

VelloreisannexedasAnnexure

P3(Pages______to_____).

11.

He also wrote to the NTAGI by writing emails addressed to Dr.

Vijaya Raghavan, Chairperson of Standing Technical SubCommitee (STSC) of NTAGI (and copying to all members of
NTAGI) requesting for the disaggregated data from Vellore in theformat provided by him as a member of NTAGI. However, theresults from Vellore were not provided. A copy of the email dated
28.05.2015 written by the petitioner to the

Chairperson STSC,NTAGI and copied to all members of NTAGI is annexed herewith
as Annexure P4 (Page______ to _____).

12.

In the mean time, an NGO also filed an RTI application seeking

information on a.) the number of cases of intussusceptions in the1000 infants given the rotavirus vaccine in Vellore limb of study
over the period of 2 years and, b.) what is the corresponding figure
for the 500 who were placebo recipients. But no reply was given to
the RTI application by the respondents. A copy of the RTI

application dated 26.05.2015 is annexed herewith as Annexure P5(Pages______to ______).

13.

Dr. Puliyel wrote a letter addressed to the Prime Minister apprising

him of the situation and requesting him to enquire into the matter. A copyof the letter dated 16.06.2015 written to the Prime Minister about
theneed for disclosure of the data is annexed herewith as Annexure P6(Pages______ to _____).

14.

In response to the letter to the Prime Minister dated 16.06.2015,

the Prime Minister’s Office made a request to the Subject Expert’sCommittee (SEC) to look at the data from Vellore. As per theminutes of the meetings of SEC dated 29.07.2015, the same has
not yet been complied with. This shows that not only the NTAGI but
even the Subjects Expert Committee has not examined the Vellore
data even after a reference for the same by the PMO. Minutes ofthe Meeting of Subject Expert Committee (SEC) – Vaccine showthat even after the PMO reference dated 22.06.2015, the SEC did
not review the data with respect to Vellore limb of the study andgave its opinion based on the already published data in the journal
Vaccine. A copy of the minutes of the meeting held on 29.07.2015
of Subjects Expert Committee is annexed herewith as Annexure
P7 (Pages_______to ______).
Why is it important to disclose centre-wise data

15.

The petitioner submits that there is a need for disclosure of thesegregated data of Vellore Centre in order to ascertain whether acertain section of the population is more susceptible to adverse
effects. This was the very objective of the clinical trial. So far the
respondents have shown complete secrecy in the matter and havenot disclosed segregated ( meaning dis-aggregated) data from allthe centres and have only released aggregated data i.e. the resultsof all three centres clubbed together.

16.

It is submitted that the revised version of Declaration of Helsinki isadopted which states that “Every research study involving humansubjects must be registered in a publicly accessible database before
recruitment of the first subject.” and that “Researchers have a duty tomake publicly available the results of their research...." Negative andinconclusive as well as positive results must be published or otherwise
made publicly available”. A copy of the relevant section of the revised
Declaration of Helsinki is annexed herewith as Annexure P8(Pages______to _____).

17.

World Health Organization (WHO) released a strong statement

advocating for public disclosure of all clinical trial results. According to it,
when data is not released it means that doctors, patients and medical
regulators cannot make informed decisions about which treatments are
best. Non-disclosure of complete clinical trial results means that
hundreds of thousands of patients have volunteered to take part inclinical trials where results have been kept hidden or are only selectively
disclosed. A copy of the ‘WHO Statement on Public Disclosure ofClinical Trial Results’ released on 14.04.2015 is annexed as Annexure
P9 (Pages_____ to _____).

18.

One of the largest online campaigning communities called Avaaz.org

starts a campaign requesting the Director, CMC Vellore to release theclinical trial data. As of now campaign has 442 signatories from the world
over but no response has been received so far from CMC Vellore. The
online petition can be accessed at:https://secure.avaaz.org/en/petition/To_The_Director_Christian_Medical_College_Vellore_632004_Release_Indian_Rotavirus_Vaccine_Trial_Da
ta/. A copy of the online petition on avaaz.org is annexed herewith asAnnexure P10 (Pages_____ to _____).

19.

Concealing of this vital data does severe injustice to thethousands of infants who participated in this study, the researchers
who painstakingly conducted the trials and the medical/scientificcommunity who depend on this data for their work. It is even morecrucial to study the segregated data because the respondents have
now launched the vaccine in 4 states in the country where lakhs ofinfants might be administereed the vaccine.

Earlier Petition by Dr. Jacob Puliyel seeking the same relief
20.

Aggrived by the attitude and callousness on the part of the

respondents a member of the National Technical Advisory Groupon Immunization (NTAGI) Dr. Jacob Puliyel had earlier filed Writ
Petition No.6913 of 2015 before the Hon’ble High Court of Delhi
praying for the ethical disclosure of the disaggregated data of all
the centres where the study was conducted. A copy of the writ
petition (civil) No. 6913 of 2015 is annexed herewith as Annexure
P11 (Pages______ to _____).

21.

Vide order dated 14.10.2015, the Hon’ble High Court dismissed

the said writ petition filed by Dr. Puliyel on the ground that
segregated trial result of all the three centres was available with the
National Technical Advisory Group on Immunization (NTAGI) of
which the petitioner therein was a member and that it was on thebasis of this data that the NTAGI had approved the said vaccine. A
copy of the order dated 14.10.2015 of the Hon’ble High Court inWrit Petition (Civil) No. 6913 of 2015 is annexed herewith asAnnexure P12 (Pages_____ to _____).

22.

The Hon’ble High Court failed to appreciate the fact that the

segregated results of the clinical trial were not made available tomembers of the NTAGI in spite of written requests for the same by
Dr. Puliyel. The details of the same are given below. Aggrieved by
the order, Dr. Puliyel was constrained to filed an SLP (C) No. 2532
of 2016 against the Order dated 14.10.2015 of the Hon’ble High

Court of Delhi. On 05.02.2016 the the Hon’ble Court while keeping
all questions open expressed its inability to entertain the said SLP
on the ground that the petitioner therein, who was a member of the
NTAGI, cannot maintain a public interest petition.

The Hon’ble

Court in the said order dated 05.02.2016 in SLP (C) No. 2532 of2016 stated as under:

Learned counsel for the petitioner seeks leave to withdraw
this petition. This petitioner cannot maintain a petition in
public interest since he was a member of the National
Technical

Advisory

Group

on

Immunization

which

recommended the introduction of the vaccine in question.
Leave to withdraw is granted. The special leave petition is
dismissed as withdrawn. All questions are left open.

A copy of the said Order dated 05.02.2016 of the Hon’ble Supreme
Court in SLP No. 2532 of 2016 is annexed as Annexure P13(Pages_____ to _____).

23.

In March 2016, the said vaccine was launched in four states -Haryana, Himachal Pradesh, Orissa and Andhra Pradesh with plans tolaunch it in other states in the next phase without making public thesegregated results (from Pune, Delhi and Vellore) of the clinical trial of
the said vaccine.

24.

The petitioner herein submits that there have been many effortson the part of the respondents to keep the segregated results ofclinical trial conducted at the three centres undisclosed. This is
despite the fact that all clinical trials conducted on humans must bereported entirely because such trials are done on the general publicwith public money and therefore the public at large has a right toknow the trial results.

25.

The instant Writ Petition is preferred on the ground that the said

study was carried out by government funding and it is the duty of
the respondents to disclose segregated data of clinical trial
involving infants and not keep it under a shroud of mystery and thesame is crucial to enable evaluation of the risks of the vaccine indifferent population groups.

26.

The petitioner herein has filed the instant writ petition espousing

the cause of ethical and complete disclosure of clinical trial
conducted on human beings. The petitioner at this stage is notraising aspertions on the efficacy of the said vaccine but is only
asking for complete segregated data to be provided to him and tomembers of NTAGI as the same is in public interest.

27.

Since the Hon’ble High Court has already expressed its views in

the matter in the earlier petition (WPC 6913 of 2015 ) filed by Dr.
Jacob Puliyel, the petitioner herein seeks the intervention of thisHon’ble Court to set aside the Order dated 14.10.2015 in WPC
6913 of 2015 of the High Court of Delhi and to direct the
respondents to place the segregated results from all the three
centres before the NTAGI, which is the expert body on
immunization policy, for examination and scrutiny and also to makethe said results public.

GROUNDS
A. Because the respondents have ignored the scientific appeals inpeer reviewed medical journal, RTIs, online appeals of thepetitioner and many others who are to gain by this scientific dataand have failed to provide the said data which can affect millions ofinfants in this country.

B. Because if the data from Vellore shows that more children who
were vaccinated had intussusceptions than the controls in Vellore,it will demonstrate that children in some areas are more susceptible
to this potentially fatal side effect.

C. Because in the said clinical trial there was an excess of 11 casesof intussusception per 10,000 vaccinated. This is 5 to 10 times
higher than the risk of intussusception with Rotashield vaccine(which was withdrawn from the market in the USA and nearly 70
times higher than the risk of intussusception with the current,internationally licensed vaccine - RotaTeq.

D. Because non-disclosure of such important data violates thebasic ethics of clinical research that require results of clinicalresearch studies to be published and brought to the knowledge ofthe medical community, participants to the research and generalpublic.

E. Because the World Health Organization (WHO) in April 2014 hasreleased a strong statement advocating for public disclosure of allclinical trial results.

F. Because when data is not released it means that doctors,
patients and medical regulators cannot make informed decisions
about which treatments are best. Non-disclosure of complete
clinical trial results means that hundreds of thousands of patients
have volunteered to take part in clinical trials where results havebeen kept hidden or are only selectively disclosed.

G. Because when researchers embark on a clinical trial, they makea commitment to conduct the trial and to report the findings inaccordance with basic ethical principles. This includes preserving
the accuracy of the results and making both positive and negative
results publicly available. Selective reporting, regardless of thereason for it, leads to an incomplete and potentially biased view of
the trial and its results. Selective reporting of clinical trial results canalso lead to wrong or unnecessary allocation of public funds, which
could otherwise have been used in public interest.

H. Because the Declaration of Helsinki, an international document
providing ethical guidance on research states that “Every researchstudy involving huan subjects must be registered in a publicly
accessible database before recruitment of the first subject.” andthat “Researchers have a duty to make publicly available the resultsof their research .... Negative and inconclusive as well as positive
results must be published or otherwise made publicly available”.

I. Because the Government of India has now launched the vaccine
in four states without making the results public and without evenproviding it to NTAGI members despite repeated requests.

J.

Because vide order dated 14.10.2015 in the earlier Writ Petition

WPC 6913 of 2015, the Hon’ble High Court stated that that the entire
segregated result of all the trial centres was available with NTAGI andthat the NTAGI approved the vaccine having examined the segregateddata. However, the Hon’ble High Court failed to appreciate the fact thatthe segregated results of the clinical trial was not made available to the
NTAGI. In fact, as a member of the NTAGI the petitioner in that writ
petition Dr. Puliyel had sought the said data but was not provided thesame.

K. Because Dr. Jacob Puliyel made a number of requests for disclosure of
the data in a peer reviewed scientific journal, to the Chairperson,
Standing Technical Sub Committee of NTAGI, to the director of CMC
Vellore, to the Prime Minister and also filed an RTI seeking thesegregated data from the different centers. However, it was notprovided to him despite the fact that he is himself a member of NTAGI
and ought to have been provided the segregated data.

L. Because the Hon’ble High Court failed in appreciating the fact that thesaid clinical trial has been conducted with government funding and thegovernment owes it to the participants and the people of this country toknow the complete segregated results.

M. Because the segregated data ought to not only be available to themembers of NTAGI but also to the general public under the Right toInformation Act.

N. Because NTAGI is the country’s apex advisory committee that provides
guidance to the national policy makers on immunization. Members of
NTAGI

includeofficials

from

MoHFW;

representatives

fromimmunization action partners such as WHO, UNICEF, the Indian
Academy of Pediatrics and the Indian Medical Association ; andleading independent experts from diverse fields such as clinicalmedicine, public health, immunology, vaccinology, immunization
program etc. The fact that the respondents cannot even trust themembers of such an exemplary committee with the complete andsegregated results of clinical trial conducted on thousands of infants
calls for an enquiry

O. Because it is mandatory to explain to future recipients the risks thathave already been seen in the Phase III trial before consent is takenfrom them for administration of the said vaccine.

P. Because informed consent requires the disclosure of safety data,and it would be unethical to proceed with immunisation without
informing the public of any risks observed with previous use of thevaccine, and not informing them what adverse effects to look out
for. The signs and symptoms of this dreaded adverse effect(namely intussusception) are the same as with dysentery(meaning the passage of blood and mucus in the stools) andunless the public are warned before hand, they would suspect
only dysentery and many deaths from intussusception will bemislabelled as dysentry.

Q. Because when data is not released it means that doctors, patients andmedical regulators cannot make informed decisions about which
treatments are best. Non-disclosure of complete clinical trial resultsmeans that hundreds of thousands of patients have volunteered to takepart in clinical trials where results have been kept hidden or are only
selectively disclosed.

R. Because the request of the Prime Minister’s Office asking the Subject
Experts Committee to look at the Vellore data has not been compliedwith in an instance of clear dereliction of responsibility by this expert
committee.

PRAYER

It is most respectfully prayed that this Hon’ble Court may be pleased
to:a.

Set aside final order/judgment dated 14.10.2015 of the Hon’ble
High Court of Delhi in WPC 6913 of 2015b.

Issue an appropriate writ directing the respondents to provide
the petitioner the complete segregated results (centre-wise data)of the clinical trial of rotavac vaccine conducted in all three
centres, including the number of intussusceptions in the 2-year
trial period ar each centrec.

Issue an appropriate writ directing the respondents to place
before the NTAGI the complete segregated results of the said
clinical trial of rotavac vaccine for examination and scrutinyd.

Issue an appropriate writ restraining the respondents from
including rotavac from Universal Immunization Policy of thegovernment of India till the complete data from the said clinical
trial is not disclosed to the key stakeholders, including thepetitioner.

e.

Issue an appropriate writ directing the respondents to frame
guidelines regarding publication of complete and segregatedresearch results in clinical trials on humans, in accordance with
the WHO statement of April 2015 on the issue.

f.

Issue such other writ, direction or order, which this Hon’ble court
may deem fit and proper under the facts and circumstances of
the case.

Drawn By: Neha Rathi
Drawn on: 19/04/2016
FILED BY:

(PRASHANT BHUSHAN)
ADVOCATE FOR THE PETITIONERNEW DELHI
FILED ON 23.04.2016

S. NO.

PARTICULARS

1.

Listing Performa

2.

Brief Synopsis and List of Dates

3.

Writ Petition with Affidavit

4.

ANNEXURE – P1 A copy of the paper titled‘Active surveillance for intussusception in aphase III efficacy trial of an oral mono-valentrotavirus vaccine in India’ published in journal
Vaccine by John & Colleagues in August 2014

5.

ANNEXURE – P2 A copy of the letter dated
06.10.2014 written by the petitioner publishedin the journal Vaccine

6.

ANNEXURE – P3 A copy of the petitioner’semail correspondence between 21.05.2015
and 28.05.2015 with Mr. Sunil Chandy,
Director, CMC Vellore

7.

ANNEXURE - P4 A copy of the email dated
28.05.2015 written by the petitioner to the
Chairperson STSC, NTAGI and copied to allmembers of NTAGI

8.

ANNEXURE – P5 A copy of the RTI
application dated26.05.2015

9.

ANNEXURE - P6 A copy of the letter dated
16.06.2015 written by the petitioner to thePrime Minister

10.

ANNEXURE - P7 A copy of the minutes ofthe meeting held on 29.07.2015 of Subjects
Expert Committee

11.

ANNEXURE – P8 A copy of the relevant
section of the revised Declaration of Helsinki
of March 201312.

ANNEXURE – P9 A copy of the ‘WHO
Statement on Public Disclosure of Clinical
Trial Results’ released on 14.04.2015

13.

ANNEXURE – P10 A copy of the online
petition on avaaz.org

14.

ANNEXURE - P11 A copy of the writ petition(civil) No. 6913 of 2015

PAGES

15.

ANNEXURE - P12 A copy of the order dated
14.10.2015 of the Hon’ble High Court in Writ
Petition (Civil) No. 6913 of 201516.

ANNEXURE - P13 A copy of the said Order
dated 05.02.2016 of the Hon’ble Supreme
Court in SLP No. 2532 of 2016